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Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear implant
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring cochlear implant, asymmetric hearing loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • English as the native language
  • Have a desire for functional binaural hearing
  • Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
  • Willingness to comply with all study requirements
  • Ability to provide informed consent

  • Poor ear (ear to be implanted):

    • Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
    • Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
    • Duration of SPHL ≥ 6 months
    • Onset of hearing loss ≥ 6 years of age

  • Better ear:

    • PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
    • Currently using a HA
    • Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%
    • Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies

Exclusion Criteria:

  • Medical condition that contraindicates surgery
  • Actively using an implantable device in the ear to be implanted
  • Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
  • Hearing loss of neural or central origin
  • Unrealistic expectations related to the benefits and limitations of cochlear implantation
  • Unwillingness or inability to comply with all investigational requirements

Sites / Locations

  • House Clinic
  • Saint Luke's Midwest Ear Institute
  • Washington University School of Medicine
  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear Implantation

Arm Description

Cochlear implantation of the poor hearing ear

Outcomes

Primary Outcome Measures

Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)
Change in Poor Ear Alone Soundfield Thresholds
Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)

Secondary Outcome Measures

Change in Sound Localization
Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)
Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)
Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)
Change in Hearing Handicap Inventory (HHIE)
Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)
Change in Health Utility Index (HUI3) Ratings
Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)
Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Change in Satisfaction With Amplification in Daily Use (SADL)
Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)
Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)
Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant
Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

Full Information

First Posted
February 9, 2017
Last Updated
December 30, 2021
Sponsor
Washington University School of Medicine
Collaborators
Midwest Ear Institute, House Clinic, Inc., NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03052920
Brief Title
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Official Title
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Midwest Ear Institute, House Clinic, Inc., NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.
Detailed Description
The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites. Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life). Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows: Hearing aid (HA) in the better ear alone HA in the poor ear alone Bilateral HAs Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study. Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows: HA in the better ear alone CI in the poor ear alone HA and CI together

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
cochlear implant, asymmetric hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implantation
Arm Type
Experimental
Arm Description
Cochlear implantation of the poor hearing ear
Intervention Type
Device
Intervention Name(s)
Cochlear implant
Other Intervention Name(s)
Cochlear America, Advanced Bionics, MED-EL
Intervention Description
Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Primary Outcome Measure Information:
Title
Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Description
Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Poor Ear Alone Soundfield Thresholds
Description
Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)
Time Frame
Pre-implant and 6 months post-implant
Secondary Outcome Measure Information:
Title
Change in Sound Localization
Description
Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
Description
Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
Description
Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear
Description
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
Description
Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Hearing Handicap Inventory (HHIE)
Description
Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Health Utility Index (HUI3) Ratings
Description
Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant
Description
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant
Description
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time Frame
Pre-implant and 12 months post-implant
Title
Change in Satisfaction With Amplification in Daily Use (SADL)
Description
Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
Description
The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant
Description
Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)
Time Frame
Pre-implant and 6 months post-implant
Title
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear
Description
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time Frame
Pre-implant and 6 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older English as the native language Have a desire for functional binaural hearing Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary Willingness to comply with all study requirements Ability to provide informed consent Poor ear (ear to be implanted): Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL) Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30% Duration of SPHL ≥ 6 months Onset of hearing loss ≥ 6 years of age Better ear: PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL Currently using a HA Aided word recognition score (CNC Word Test) at 60 dB SPL > 40% Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies Exclusion Criteria: Medical condition that contraindicates surgery Actively using an implantable device in the ear to be implanted Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted Hearing loss of neural or central origin Unrealistic expectations related to the benefits and limitations of cochlear implantation Unwillingness or inability to comply with all investigational requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
House Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Saint Luke's Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34126876
Citation
Sampathkumar R, Kaehne A, Kumar N, Kameswaran M, Irving R. Systematic review of cochlear implantation in adults with asymmetrical hearing loss. Cochlear Implants Int. 2021 Nov;22(6):311-329. doi: 10.1080/14670100.2021.1936363. Epub 2021 Jun 14.
Results Reference
derived

Learn more about this trial

Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

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